Clearance Summary
DIGITAL CLINICAL THERMOMETER MODEL V9XX received FDA 510(k) clearance under submission number K082266, sponsored by Amperor-Electronic(Sz) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2008-11-07.
- Submission: K082266
- Applicant / Sponsor: Amperor-Electronic(Sz) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2008-11-07
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.